Statistical Programmer II

When our values align theres no limit to what we can achieve.

At Parexel we all share the same goal - to improve the worlds health. From clinical trials to regulatory consulting and market access every clinical development solution we provide is underpinned by something special - a deep conviction in what we do.

Each of us no matter what we do at Parexel contributes to the development of a therapy that ultimately will benefit a patient. We take our work personally we do it with empathy and were committed to making a difference.

Job Location: 275 Grove Street Suite 101C Newton MA 02466 and position may telecommute from anywhere in the United States 5 days per week.

Job Title: Statistical Programmer II

Duties: Parexel International LLC seeks a Statistical Programmer II reporting to headquarters in Newton Massachusetts to conduct statistical programming. Use programming techniques to produce derived datasets (e.g. SDTM ADaM) tables figures and data listings in compliance with CDISC standards. Provide technical expertise for clinical trials and support programming activities related to analysis and reporting of clinical study data. Assist in project start-up activities creation of global programs tracking spreadsheets and other required documentation. Create files and reviewer guides for inclusion in regulatory submissions. Use efficient programming techniques to quality control low-medium complexity derived datasets tables figures and data listings. Produce Tables Listings and Figures (TLFs) for clinical study reports regulatory submissions and publications. Assist in the production and quality control of derived dataset specifications and other process supporting documents and submission documentation. Implement statistical analysis plans (SAPs) by writing SAS code. Provide training and mentorship to staff and project teams. Maintain all supporting documentation for studies in accordance with SOPs and guidelines to ensure traceability and regulatory compliance. Ensure compliance with SOPs guidelines ICH-GCP and any other applicable local and international regulations and participate in internal and external audits and regulatory inspections. Participate in process/quality improvement initiatives and work with P21 Enterprise version. Position may telecommute from anywhere in the United States 5 days per week. Annual salary: $115790.20 - $132400.

Requirements: Bachelors degree in Statistical Programming Mathematics Statistics Data Analytics Business Administration or a related field plus 5 progressive years of statistical programming experience. Must have five years of experience in each of the following: (1) Developing and validating SAS programs for clinical trial data analysis including data cleaning data integration and report generation; (2) Creating and maintaining Analysis Data Model (ADaM) datasets in compliance with CDISC standards; (3) Producing Tables Listings and Figures (TLFs) for clinical study reports regulatory submissions and publications; (4) Implementing statistical analysis plans (SAPs) by writing SAS code; (5) Performing quality control checks on SAS programs and outputs produced by other team members; (6) Maintaining and utilizing standard SAS macros and tools including Base Stat Macro EG Studio Graph ODS and Report; (7) Creating files and reviewers guides for inclusion in regulatory submissions; (8) Working with ICH-GCP and 21 CFR Part 11.

To apply please send resume to and cite requisition number 00979 or apply at . This position is subject to the companys Employee Referral Program.

EEO Disclaimer
Parexel is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to legally protected status which in the US includes race color religion sex sexual orientation gender identity national origin disability or protected veteran status.